Aktas M, Radke T F, Strauer B E, Wernet P, Kogler G
Institute for Transplantation Diagnostics and Cell Therapeutics, University of Duesseldorf Medical School, Duesseldorf, Germany.
Cytotherapy. 2008;10(2):203-11. doi: 10.1080/14653240701851324.
The Düsseldorf-based cardiologist Professor Strauer was the first to present a therapeutic concept for the repair of acute infarcted myocardium in 2001: the autologous intracoronary transplantation of unfractionated human bone marrow (BM) mononuclear cells (MNC). The Division of Cardiology, Pneumology and Angiology, University of Duesseldorf Medical School, Duesseldorf, Germany, was also able to show the regenerative potential of BM stem cell transplantation in patients with chronic heart disease (CHD) and peripheral arterial disease (PAD). In the mean time, several clinical trials have been set up worldwide, predominantly by using MNC isolated manually from BM aspirates via density-gradient centrifugation; 374 patients have been treated here with unselected BM MNC since 2001. Altogether 217 BM aspirates have been processed manually. In order to maintain the high standards required for cellular therapeutics, the Sepax cell-separation system was implemented into routine BM processing in 2006. The closed Sepax system provides a reproducible MNC isolation method, and 157 BM samples have been processed with the Sepax device. The results of manual MNC isolation were compared with the Sepax-mediated MNC isolation.
The manual Ficoll separation method was compared with the Sepax density gradient-based separation (DGBS) protocol using Ficoll with the kit CS-900 and the Sepax S-100 main processing unit from Biosafe.
Nucleated cell and MNC recovery were significantly higher after Sepax processing (P<0.0001) whereas no significance was found for red blood cell depletion.
The Sepax cell-separation system is a time-saving method providing clinical-grade MNC isolated automatically from human BM by Ficoll density centrifugation.
位于杜塞尔多夫的心脏病专家施特劳尔教授于2001年首次提出了修复急性梗死心肌的治疗理念：未分级人骨髓（BM）单个核细胞（MNC）的自体冠状动脉内移植。德国杜塞尔多夫大学医学院心脏病学、肺病学和血管病学系也证实了BM干细胞移植对慢性心脏病（CHD）和外周动脉疾病（PAD）患者的再生潜力。与此同时，全球范围内开展了多项临床试验，主要是通过密度梯度离心从BM抽吸物中手动分离MNC；自2001年以来，已有374例患者接受了未分选的BM MNC治疗。总共手动处理了217份BM抽吸物。为了维持细胞治疗所需的高标准，2006年将Sepax细胞分离系统应用于常规BM处理。封闭式Sepax系统提供了一种可重复的MNC分离方法，已使用Sepax设备处理了157份BM样本。将手动MNC分离结果与Sepax介导的MNC分离结果进行了比较。
将手动Ficoll分离方法与使用Biosafe公司的试剂盒CS-900和Sepax S-100主处理单元、基于Ficoll的Sepax密度梯度分离（DGBS）方案进行比较。
Sepax处理后有核细胞和MNC回收率显著更高（P<0.0001），而红细胞清除率无显著差异。
Sepax细胞分离系统是一种省时的方法，可通过Ficoll密度离心从人BM中自动分离出临床级MNC。
